Product Assessment Report

Toelatingsnummer 14344 N
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 TOELATING
Gelet op de aanvraag d.d. 13 augustus 2013 (20131174 TNBWE) van
Physalys sarl
3 Rue de L 'Arrivee
F-75749 PARIS ,CEDEX 15
FRANKRIJK
tot verkrijging van een toelating als bedoeld in artikel 19 van de Verordening (EU) 528/2012, op
basis van de werkzame stof alfachloralose,
Rentokil Alpha Rapid Bait Blocks
Mede gelet op artikel 89 lid 2 juncto artikel 91 van de Verordening (EU) 528/2012, juncto artikel
44, eerste lid, Wet gewasbeschermingsmiddelen en biociden zoals deze luidde voor de
inwerkingtreding van Verordening (EU) 528/2012
BESLUIT HET COLLEGE als volgt:
1.1 Toelating
1. Het middel Rentokil Alpha Rapid Bait Blocks is toegelaten voor de in bijlage I
genoemde toepassingen onder nummer 14344 N met ingang van datum dezes. Voor
de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.
2. De toelating geldt tot 30 juni 2021.
1.2 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.3 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I bij dit
besluit is voorgeschreven.
1.4 Classificatie en etikettering
Gelet op artikel 50 Wet gewasbeschermingsmiddelen en biociden worden voorschriften
gegeven.
Dit leidt tot de volgende voorschriften:
De aanduidingen, welke moeten worden vermeld, worden hierbij vastgesteld als volgt:
aard van het preparaat: Lokmiddel (klaar voor gebruik)
werkzame stof:
alfachloralose
gehalte:
3,4 %
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
PICTOGRAM(MEN)
pictogram:
GHS09-milieu
SIGNAALWOORD
Waarschuwing
Gevarenaanduidingen
H400
Voorzorgsmaatregelen
P102
P273
P501
Zeer giftig voor in het water levende organismen.
Buiten het bereik van kinderen houden.
Voorkom lozing in het milieu.
Inhoud/verpakking afvoeren naar inzamelpunt voor gevaarlijk of
bijzonder afval.
Behalve de voorgeschreven aanduidingen en vermeldingen moeten op de verpakking
voorkomen:
a. letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.
b. hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede
bestrijding mits deze niet met die tekst in strijd zijn.
2 DETAILS VAN DE AANVRAAG
Het betreft een aanvraag tot verkrijging van een toelating van het middel Rentokil Alpha Rapid
Bait Blocks (14344 N), een middel op basis van de werkzame stof alfachloralose. Het middel
wordt aangevraagd als middel ter bestrijding van huismuizen in afgesloten ruimten.
2.2 Informatie met betrekking tot de stof
Er zijn in Nederland eerder middelen op basis van de werkzame stof alfachloralose toegelaten.
De werkzame stof alfachloralose is bij Richtlijn 2009/93/EG, dd 31 juli 2009 van de Europese
Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn 98/8/EG
voor pt14.
2.3 Karakterisering van het middel
Rentokil Alpha Rapid Bait Blocks is a solid fat based green triangle block. It is designed for
placing inside tamper resistance bait boxes which are designed to permit pest controllers easy
retrieval of uneaten bait at the end of a treatment for re-use where possible. It is used for the
control of mice and can only be used indoors. The product is for professional use only.
Alphachloralose acts by retarding the metabolic processes. It acts on the nervous system
causing a depression in brain activity, slowing the heart and respiration. This results in a
lowering of body temperature, causing the mouse to die of hypothermia.
2.4 Voorgeschiedenis
De aanvraag is op 26 augustus 2013 ontvangen; op 7 november 2013 zijn de verschuldigde
aanvraagkosten ontvangen.
2.5 Eindconclusie
Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Rentokil
Alpha Rapid Bait Blocks op basis van de werkzame stof alfachloralose voldoende werkzaam en
heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu.
Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage
2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet
bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een
bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en
biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid
van het elektronisch indienen van een bezwaarschrift opengesteld.
Wageningen, 7 maart 2014
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN,
ir. J.F. de Leeuw
voorzitter
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE I bij het besluit d.d. 7 maart 2014 tot toelating van het middel Rentokil Alpha Rapid
Bait Blocks, toelatingnummer 14344 N
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het gebruik als middel ter bestrijding van huismuizen in afgesloten
ruimten, met dien verstande, dat het middel moet worden uitgelegd in speciaal hiervoor
bestemde lokaasdoosjes. Plaats het lokaas in lokaasdoosjes buiten bereik van andere dieren
(bijvoorbeeld vogels, zoogdieren, huis- of landbouwdieren) en kinderen. Verwijderd houden van
eet- en drinkwaren en van diervoeder.
De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden.
Het middel is uitsluitend bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
Toepassingen:
Alpha Rapid Bait Blocks is een kant-en-klaar lokaasblokje tegen huismuizen dat uitsluitend
binnenshuis mag worden toegepast. De blokjes wegen 5 of 10 gram. Alpha Rapid Bait Blocks
is een acuut werkend rodenticide en eenmalige opname is doorgaans genoeg om snel
resultaat te bereiken. Alpha Rapid Bait Blocks wordt toegepast voor bestrijdingsperioden van 710 dagen.
Het product is minder effectief bij temperaturen boven de 16°C.
Plaats het lokaas in de hiervoor geschikte lokaasdoosjes of -kisten. De doosjes of kisten
vervolgens uitzetten op plaatsen waar de muizen geregeld komen: in de nabijheid van
holingangen, op looppaden (sporen!), in verborgen ruimten zoals verlaagde plafonds en op
plaatsen waar de dieren voedsel halen of knagen. Het middel dient gedurende een aantal
dagen in voldoende mate te worden gegeten door de knaagdieren.
Plaats het lokaas in lokaasdozen buiten bereik van andere dieren (bijvoorbeeld vogels,
zoogdieren, huis- of landbouwdieren) en kinderen. Het lokaas zo vastmaken dat het niet
weggesleept kan worden. De lokaasdoosjes niet toepassen in de buurt van
waterafvoersystemen waar het middel met water in contact kan komen. De lokaasdoosjes
markeren zodat duidelijk is dat ze rodenticide bevatten. Na gebruik handen wassen.
Dosering:
Plaats de lokaasdoosjes op een afstand van 1-3 meter van elkaar. Vul de lokaasdoosjes met
20 gram lokaas per lokaasdoosje.
Vervolg bestrijdingsactie:
Controleer de eerste opname na 3 dagen en vervolgens regelmatig op basis van opname
(wekelijks of elke 14 dagen). Ververs of vul het lokaas daar waar nodig is aan tot er in het
geheel geen opname meer plaatsvindt. Middel dat beschimmeld of verontreinigd is totaal
vervangen. Indien het lokaas geheel opgegeten is, onmiddellijk lokaas hervullen en meer
lokaaspunten inrichten en/of de controlefrequentie verhogen. In de meeste gevallen zal de
bestrijding met behulp van dit middel binnen 10 dagen voltooid zijn. Indien na 10 dagen nog
activiteit van muizen wordt waargenomen, moet de mogelijke oorzaak hiervan worden
onderzocht en maatregelen worden getroffen. Nadat de opname van lokaas gestopt is, de
resten van het lokaas verzamelen en veilig verwijderen als gevaarlijk afval (cf. Eural).
Dode dieren verzamelen en in plastic verpakt in het vuilnisvat deponeren, opdat huisdieren en
andere dieren niet door het opeten van de kadavers worden vergiftigd. Katten en honden
tijdens een bestrijdingsactie extra goed voeren. Verder de nodige maatregelen (laten) treffen in
het belang van muiswering (ingangen afdichten, mogelijk voer verwijderen, etc.). Indien in
aangebouwde ruimten muizen aanwezig zijn, zullen de resultaten slechts blijvend zijn, wanneer
ook daar een bestrijdingsactie wordt uitgevoerd.
Gebruik van dit middel moet worden gecombineerd met de implementatie van een integrated
pest management systeem (IPM).
Resistentiemanagement:
Voor de werkzame stof aanwezig in het middel, alphachloralose, is er een risico dat muizen
resistentie ontwikkelen. Gebruik dit middel daarom bij voorkeur niet bij temperaturen hoger dan
16oC en in gevallen dat resistentie waarschijnlijk is, bijvoorbeeld in gevallen dat vorige
bestrijdingsacties met alphachloralose bevattende middelen niet hebben geresulteerd in een
duidelijke vermindering van de populatie. Gebruik dan een middel met een andere actieve stof
en een andere werking.
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE II bij het besluit d.d. 7 maart 2014 tot toelating van het middel Rentokil Alpha
Rapid Bait Blocks, toelatingnummer 14344 N
Product Assessment Report
Mutual Recognition
Rentokil Alpha Rapid Bait Blocks
31-01-2014
Internal registration/file no:
20131174
Authorisation/Registration no:
14344N
Granting date/entry into force of
authorisation/ registration:
Expiry date of authorisation/
registration:
07-03-2014
Active ingredient:
Alphachloralose
Product type:
14
30-06-2021
Biocidal product assessment report related to product
authorisation under Regulation 528/2012/EC
Contents
1
General information about the product application ................... 1
1.1
Applicant ............................................................................................................................ 1
1.2
Current authorisation holder .............................................................................................. 1
1.3
Proposed authorisation holder .......................................................................................... 1
1.4
Information about the product application ......................................................................... 1
1.5
Information about the biocidal product .............................................................................. 1
2
Summary of the product assessment.......................................... 2
2.1
Identity related issues ........................................................................................................ 2
2.2
Classification, labelling and packaging ............................................................................. 2
2.2.1 Proposal for the classification and labelling of the formulation concerning physical
chemical properties .............................................................................................. 2
2.2.2 Proposal for the classification and labelling of the formulation concerning health3
2.2.3 Proposal for the classification and labelling of the formulation concerning the
environment .......................................................................................................... 3
2.3
Physico/chemical properties and analytical methods ....................................................... 4
2.4
Risk assessment for Physico-chemical properties ............................................................ 4
2.5
Effectiveness against target organisms ............................................................................ 4
2.6
Exposure assessment ....................................................................................................... 4
2.6.1 Description of the intended use(s)........................................................................ 4
2.6.2 Assessment of exposure to humans and the environment .................................. 4
2.7
Risk assessment for human health ................................................................................... 7
2.8
Risk assessment for the environment ............................................................................... 7
2.9
Measures to protect man, animals and the environment .................................................. 8
3
Proposal for decision .................................................................. 10
1
General information about the product
application
1.1
Applicant
Physalys SARL
Rue de l’Arrivee 3
BP215-F75749
Paris, Cedex 15
France
1.2
Current authorisation holder1
Not applicable
1.3
Proposed authorisation holder
Physalys SARL
1.4
Information about the product application
Application for authorisation based on mutual recognition. The primary
assessment has been carried out by reference member state UK.
1.5
Information about the biocidal product
Productname: Rentokil Alpha Rapid Bait Blocks
Productname in RMS: Physalys Expresse Professional
PT: 14
Active substance: Alphachloralose
1
Applies only to existing authorisations
2
Summary of the product assessment
2.1
Identity related issues
For the assessment of the identity related issues we refer to Product Assessment Report of
the original authorisation.
2.2
Classification, labelling and packaging
2.2.1
Proposal for the classification and labelling of the formulation
concerning physical chemical properties
No classification is required based on the physical and chemical properties of the product
based on Reg (EC) 1272/2008.
Supported shelf life of the formulation: 24 months in polyethylene and polystyrene
The proposed classification and labelling of the preparation is identical to that proposed in
the Product Assessment Report by the competent authority UK.
Professional use
Packaging size and
type
Packaging size and
type
Packaging authorised/
evaluated by RMS
Cardboard outer
packaging containing a
polythene inner pack with
a polystyrene tray
containing up to 12
‘winged inserts’; each
winged insert contains a
5g solid bait block
Packaging applied for
in NL
Cardboard outer
packaging containing
a polythene inner pack
with a polystyrene tray
containing up to 12
‘winged inserts’; each
winged insert contains
a 5g solid bait block*
Packaging authorised
in NL
Cardboard outer
packaging containing
a polyethylene inner
pack with a
polystyrene tray
containing up to 12
‘winged inserts’; each
winged insert contains
a 5g solid bait block
containing a minimum
of 800g per packaging
Cardboard outer
Cardboard outer
Cardboard outer
packaging containing a
packaging containing packaging containing
polythene inner pack with a polythene inner pack a polyethene inner
a polyethylene moulded
with a polyethylene
pack with a
tray; each tray contains up moulded tray; each
polyethylene moulded
to forty-eight 5g or 10 g
tray contains up to
tray; each tray
solid bait blocks.
forty-eight 5g or 10 g
contains up to fortysolid bait blocks.*
eight 5g or 10 g solid
bait blocks containing
a minimum of 800g
per packaging
*To comply with the Dutch requirement that rodenticide packagings for professional use
should contain a minimum amount of product of 800g, the applicant will pack multiple trays
per outer packaging.
2.2.2
Proposal for the classification and labelling of the formulation
concerning health
The identity of all substances in the mixture that contribute to the classification of
the mixture *:
Pictogram:
Signal word:
H-statements:
P-statements:
P102
Keep out of the reach of children
Supplemental Hazard information:
Child-resistant fastening obligatory?
Not applicable
Tactile warning of danger obligatory?
Not applicable
Explanation:
Pictogram:
H-statements:
P-statements:
No P-statements have been proposed by the applicant.
Based on the risk assessment for children, P102 is
assigned by the Ctgb.
Other:
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
2.2.3
Proposal for the classification and labelling of the formulation
concerning the environment
Professional use
Pictogram:
H-statement:
P-statements:
Supplemental Hazard
information:
Explanation
Pictogram:
H-statement:
P-statements:
Other:
GHS09
H400
P273
P501
Signal word:
Warning
Very toxic to aquatic life.
Avoid release to the environment.
Dispose of contents/container to hazardous or special waste
collection point
-
Classification based on toxicity of the active substance and the triggers
laid down in Regulation (EC) 1272/2008
Classification based on toxicity of the active substance and the triggers
laid down in Regulation (EC) 1272/2008
The applicant proposed P-statements P273 and P501. The proposal of
the applicant has been accepted.
-
The proposed classification and labelling of the preparation deviates from that proposed in the
Product Assessment Report by the competent authority (R50/53 – Very toxic to aquatic organisms,
may cause long term adverse effects in the aquatic environment). No chronic data are available and
due to the rapidly degradability of the substance, according to CLP guidelines, the acute data could
not be used as chronic data for the active substance. Therefore, the H-statement does not include
‘Owith long lasting effects.’
2.3
Physico/chemical properties and analytical methods
For the assessment of the physical and chemical properties we refer to Product
Assessment Report of the original authorisation.
2.4
Risk assessment for Physico-chemical properties
For the risk assessment for physico-chemical properties we refer to Product Assessment
Report of the original authorisation.
2.5
Effectiveness against target organisms
For the assessment of the effectiveness against target organisms we refer to Product
Assessment Report of the original authorisation. The conclusions of the RMS are
acceptable.
2.5.1
The label claim
The applicant has provided a Dutch label (WG/GA). This has been adapted to our
standards.
Professional/non-professional use
In the PAR efficacy was demonstrated for professional and non-professional use. However,
authorisation for this product in NL was only requested for professional use.
2.6
Exposure assessment
2.6.1
Description of the intended use(s)
For the description of the intended use(s) we refer to Product Assessment Report of the
original authorisation.
2.6.2
Assessment of exposure to humans and the environment
Toxicology
For the assessment of the exposure to humans we refer to Product Assessment Report of
the original authorisation.
The formulation Rentokil Alpha Rapid Bait Blocks is a wax block bait containing 4%
alphachloralose as active substance and is intended for the use against mice inside
buildings (PT14). The intended maximal dose is 10 g formulation per one bait point. The
formulation is supplied in polystyrene trays containing “winged inserts”, each containing 5 g
solid blocks, or in polyethylene trays containing solid bait blocks of 5 g and 10 g and is
intended for professional use only. The plastic winged inserts are designed that the
operator would not need to touch the bait block during the loading. The operator detaches
the section of the tray containing the bait block by holding the plastic “wings”. The Product
Assessment Report (PAR) was prepared by the RMS UK.
Alphachloralose is an existing active substance, included in the Union List of Approved
Substances under Regulation 528/2012/EC . The classification and labelling of
alphachloralose in the PAR is identical to classification and labelling of brodifacoum in the
final CAR of alpha-chlorasole (2007, RMS Portugal).
The applicant has proposed the read-across of the formulation data with the reference
products Alphablock and Alphakil Block in the CAR of alpha-chlorasole. This suggestion
was accepted by the RMS UK and is also considered acceptable by the Ctgb. However, no
studies with the formulations Alphablock and Alphakil Block were submitted at the stage of
the substance evaluation by the RMS Portugal, therefore classification and labelling will be
performed based on the calculation rules according to Regulation 1272/2008/EC.
For dermal absorption the value of 3.11% was derived in the CAR of alphachloralose
based on the study with the reference product. The RMS UK considered it acceptable to
use this value in the risk assessment of Rentokil Alpha Rapid Bait Blocks. The Ctgb agrees
with the RMS.
The following AEL values were derived in the CAR of alphachloralose: AELlong-term, medium term
= 0.15 mg/kg bw/day and AELacute of 0.2 mg/kg bw/day. The same values were used in the
risk assessment by the RMS UK.
The exposure assessment was performed by the RMS UK in the same way as the
exposure assessment in the CAR of alpha-chlorasole. The exposure estimates were
derived based on the operator exposure study, in which professional operator were placing
alpha-chlolase bait blocks into bait boxes. Two different bait box loading scenarios were
included in the study, the loading of the bait box with 10 g solid bait block, or loading or the
bait box with the “winged inserts” of 5 g. For two scenarios, either five or seven operators
were handling 100 blocks to load 50 bait boxes each.
The following assumptions were used to determine professional exposure:
- The operator loads 30 new bait boxes per day (visiting 2 sites and placing 15 new boxes
at each site) and cleans 20 boxes per day
- The exposure during placing of 15 boxes was recalculated from the indicative exposure
for the loading of 50 bait boxes derived in the study, by developing a regression model
which took into account that exposure after only a single manipulation is higher than would
be expected by simple interpolation when manipulations are repeated. Using this model the
ratio for converting from 50 bait boxes to 15 is 3.1.
There were no exposure data for the cleaning of the boxes, but it was presumed that
securing blocks in the bait boxes will lead to higher exposure than during the cleaning.
Therefore the exposure during cleaning was presumed to be equal during the exposure
during the loading. Using the regression model conversion factor from 50 bait boxes to 20
was 2.4.
Based on this the following internal exposure estimates were derived in the CAR of
alphachloralose and taken over in the PAR by the RMS UK, considering 4% concentration
of alphachloralose in the formulation, 3.11% dermal absorption and 60 kg professional user
body weight:
For the loading of 30 bait boxes with “winged inserts”: 0.001 mg/kg bw/day
For the loading of 30 bait boxes with solid blocks: 0.011 mg/kg bw/day
For the cleaning of 20 bait boxes: 0.014 mg/kg bw/day.
In total:
Loading to 30 bait boxes with “winged inserts” and cleaning of 20 bait boxes: 0.015 mg/kg
bw/day
Loading of 30 bait boxes with solid blocks and cleaning of 20 bait boxes: 0.025 mg/kg
bw/day.
It should be noted that according to the HEEG opinion endorsed at TM III 2010 on the
harmonization of manipulations in the assessment of rodenticides the performance of 60
loading and 15 cleaning operations per day for professional user needs to be considered.
However, the HEEG opinion is aimed at anticoagulant rodenticides, where alphachloralose
is a CNS depressant. Therefore the exposure estimates as derived in the CAR of
alphachloralose are considered acceptable by the Ctgb.
If these values are compared with the AELmedium/long-term of 0.15 mg/kg bw/day, the following
risk indices are derived:
For the “winged inserts”: (0.015/0.15 =) 0.1
For the solid blocks: (0.025/0.15 = ) 0.17.
Based on this no adverse effects from exposure to alphachloralose is expected for
unprotected professional users due to the application of Rentokil Alpha Rapid Bait Blocks
supplied as “winged inserts” of 5 g or solid blocks of 10 g against mice.
The RMS UK has also assessed two secondary exposure scenarios, which were also
assessed in the CAR of alphachloralose: exposure of an adult or a child handling a dead
rodent, or exposure of an infant incidentally ingesting the bait. For the handling of dead
rodent a dislodgeable amount of 1 g is assumed. Considering body weights of 60 kg for an
adult and 15 kg for a child, 4% alphachloralose concentration and 3.11% dermal
absorption, the resulting systemic exposure is 0.021 mg/kg bw/day and 0.082 mg/kg
bw/day for an adult and a child, respectively.
As adults and children are not expected to handle dead rodents on a regular basis, the
derived exposure estimates can be compared with the AELacute of 0.2 mg/kg bw/day. In that
case the following risk indices are derived:
For an adult: 0.021/0.2 = 0.11
For a child: 0.082/0.2 = 0.41
For an infant incidentally ingesting the bait an ingestion of either 10 mg bait is assumed
according to TNsG, or 5 g based on the user guidance. Based on this the following internal
exposure estimates are derived (considering 4% concentration, 100% oral absorption and
10 kg body weight):
For the ingestion of 10 mg of bait:
10 x 4% x 100% /10 = 0.04 mg/kg bw/day.
For the ingestion of 5 g of bait:
5000 x 4% x 100% /10 = 20 mg/kg bw/day
As the ingestion of a bait is expected to occur only incidentally, the derived exposure
estimates can be compared with the AELacute of 0.2 mg/kg bw/day. In that case the
following risk indices is derived:
For the ingestion of 10 mg of bait: (0.04 / 0.2 = ) 0.2.
For the ingestion of 5 g of bait: (20 / 0.2 = ) 100.
Based on this, no adverse effects are expected for the secondary exposure of adults and
children of alpha-chlorasole from handling the dead rodents, or for an infant incidentally
ingesting 10 mg of bait. The formulations contains a bittering agent, which reduces the
amount ingested; however, adverse effects for an infant incidentally ingesting 5 g of bait
cannot be excluded.
Therefore the following precautionary phrases should be added to the product label:
- Keep out of the reach of children (P102)
- Prevent access to bait by children, domesticated animals and pets, (particularly cats,
dogs and pigs).
When these risk management measures are taken into consideration, the risk of secondary
exposure for children is considered to be mitigated.
Environment:
The product is intended for the professional control of mice indoors. Exposure of the
environment may occur through landfill, after deposition of dead mice. As the active
substance is mobile in soil and the intended use is indoors, exposure of the soil
compartment (agricultural soil and grasslands) is considered negligible and was not
considered. Exposure of the water compartment has been considered.
For details on the assessment of the exposure to the environment we refer to Product
Assessment Report of the original authorisation.
2.7
Risk assessment for human health
For the risk assessment for human health we refer to Product Assessment Report of the
original authorisation.
Based on the risk assessment, no adverse effects are expected for unprotected
professional user from the exposure to alphachloralose due to the application of Rentokil
Alpha Rapid Bait Blocks supplied as “winged inserts” or solid wax blocks against mice.
Based on the risk assessment, adverse effects from exposure of alphachloralose for an
infant incidentally ingesting 5 g of Rentokil Alpha Rapid Bait Blocks bait cannot be
excluded. Therefore the following precautionary phrases should be added to the product
label:
- Keep out of the reach of children (P102)
- Prevent access to bait by children, domesticated animals and pets, (particularly cats,
dogs and pigs).
When these risk management measures are taken into consideration, the risk of secondary
exposure for children is considered to be mitigated.
2.8
Risk assessment for the environment
The product contains the active substance alphachloralose (4% w/w).
In addition to alphachloralose, the product contains SoC1 (0.005% w/w) and SoC2 (max
0.012% w/w). These substances have been identified as potential substances of concern
for the environment, with risk statements H410 for SoC1 and H412 for SoC2. These
substances are not present in sufficient concentrations to the classification of the biocidal
product according to Regulation EC 1272/2008. Therefore, there is no need to consider
these substances further in the risk assessment.
In addition, alphachloralose is considered non-biodegradable and hydrolytically stable, and
therefore metabolites are not considered in the risk assessment as their environmental
risks are expected to be covered by the parent substance alphachloralose.
The intended use of Rentokil Alpha Rapid Bait Blocks is the professional control of mice
indoors only. Risks of exposure of the active substance to groundwater, STP and the
freshwater compartment through landfill, was determined and considered acceptable. As
the active substance is not likely to bioaccumulate, the risk for secondary poisoning is
expected to be negligible. Furthermore, as the active substance does not clearly fulfil the B
criterion, it is not considered to be a PBT or vPvB substance. For details on the risk
assessment for the environment we refer to Product Assessment Report of the original
authorisation.
Overall conclusion for the aspect environment: The conclusions in the risk assessment
of the RMS are valid.
2.9
Measures to protect man, animals and the environment
Measure
In WG/GA
For professional use only
Yes
For indoor use only
Yes
Prevent access to bait by children, birds
and non-target animals (particularly
dogs, cats, pigs and poultry).
For use only in tamper-resistant bait
stations. Keep containers tightly closed
and do not try to open boxes or use the
material in any way other than as
directed.
Yes
Yes
WG/GA (in Dutch)
Het middel is uitsluitend bestemd voor
professioneel gebruik.
In afgesloten ruimten
Plaats het lokaas in lokaasdozen buiten
bereik van andere dieren (bijvoorbeeld
vogels,
zoogdieren,
huisof
landbouwdieren) en kinderen
Toegestaan is uitsluitend het gebruik als
middel ter bestrijding van muizen in
afgesloten ruimten met dien verstande,
dat het middel moet worden uitgelegd in
speciaal
hiervoor
bestemde
lokaasdoosjes.
Alpha Rapid Bait Blocks wordt toegepast
voor bestrijdingsperioden van 7-10
dagen.
Bait should be laid for periods of at
most 7-10 days.
Yes
Baits must be securely deposited in a
way so as to minimize the risk of
consumption by other animals or
children.
Yes
Plaats het lokaas buiten bereik van
dieren (bijvoorbeeld vogels, zoogdieren,
huis- of landbouwdieren) en kinderen.
Where possible, secure baits so that
they cannot be dragged away.
Yes
Het lokaas zo vast maken dat het niet
weggesleept kan worden.
Search for and remove dead rodents at
frequent intervals during treatment
(unless used in sewers), at least as
often as when baits are checked and/or
replenished. Daily inspection may be
required in some circumstances.
Yes
Dispose of dead rodents in accordance
with local requirements. In the UK
Yes
Dode dieren verzamelen en in plastic
verpakt in het vuilnisvat deponeren,
opdat huisdieren en andere dieren niet
door het opeten van de kadavers
worden vergiftigd.
poisoned rodents may be disposed of
by the waste producer at an incinerator
or landfill permitted to accept that type
of waste, or collected by a registered
waste carrier and taken for disposal at a
suitably permitted site. For further
information on disposal contact the
Environment
Agency
(http://www.environmentagency.gov.uk)
or
SEPA
(http://www.sepa.org.uk ).
Particulars of likely direct or indirect
adverse effects and first aid instructions
–
Excessive concentrations may cause
nervous
system
depression,
cv
headache and weakness leading to
unconsciousness. No antidote. Treat
symptomatically
Nee
The first aid measures are usually not
included in WG/GA, unless it concerns a
specific antidote (which is not available
in this case).
Additional:
Na gebruik handen wassen
Het gebruik van dit middel is alleen
toegestaan indien het een onderdeel
vormt van
een
integrated
pest
management systeem (IPM).
Het product is minder effectief bij
temperaturen boven de 16°C
De lokaasdozen niet toepassen in de
buurt van waterafvoersystemen waar het
middel met water in contact kan komen
Katten
en
honden
tijdens
een
bestrijdingsactie extra goed voeren
3
Proposal for decision
The authorisation of Rentokil Alpha Rapid Bait Blocks is based on mutual recognition of the
authorisation of RMS UK. For the evaluation we refer to the product assessment report
which has been composed by the RMS conform the Common Principles.
It is concluded that the application of Rentokil Alpha Rapid Bait Blocks according to the use
instructions, will be effective and that there will be no harm for the health of humans and for
the environment.
Proposal for the classification and labelling of the formulation
Based on the profile of the substance, the provided toxicology of the preparation, the
characteristics of the co-formulants, the method of application and the risk assessment, the
following labelling of the formulation is proposed:
The identity of all substances in the mixture that contribute to the classification of
the mixture *:
Pictogram:
GHS09
Signal word:
Warning
H-statements:
H400
Very toxic to aquatic life.
P-statements:
P102
Keep out of the reach of children
P273
Avoid release to the environment
P501
Dispose of contents/container to hazardous or
special waste collection point
Supplemental Hazard information:
Child-resistant fastening obligatory?
Not applicable
Tactile warning of danger obligatory?
Not applicable

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